View:
August 15, 2024
Dajun Yang
Chairman and Chief Executive Officer
Ascentage Pharma Group International
68 Xinqing Road
Suzhou Industrial Park
Suzhou, Jiangsu
China
Re: Ascentage Pharma Group International
Amendment No. 1 to Draft Registration Statement on Form F-1
Submitted July 31, 2024
CIK No. 0002023311
Dear Dajun Yang:
We have reviewed your amended draft registration statement and have the
following
comments.
Please respond to this letter by providing the requested information
and either submitting
an amended draft registration statement or publicly filing your registration
statement on EDGAR.
If you do not believe a comment applies to your facts and circumstances or do
not believe an
amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to this letter
and your amended
draft registration statement or filed registration statement, we may have
additional
comments. Unless we note otherwise, any references to prior comments are to
comments in our
July 12, 2024, letter.
Amendment No. 1 to Draft Registration Statement on Form F-1 Submitted July 31,
2024
Cover Page
1. We note the following statement on the cover page and elsewhere
throughout the
prospectus: "Ascentage Pharma Group International s ability to pay
dividends, if any, to
its shareholders and to service any debt it may incur will partially
depend upon dividends
paid by PRC subsidiaries." Please revise your disclosure, both on the
cover page and
elsewhere as appropriate, to clarify whether the company's PRC
subsidiaries have ever
paid dividends to Ascentage Pharma Group International. In addition,
describe any
restrictions on foreign exchange and your ability to transfer cash
between entities, across
August 15, 2024
Page 2
borders, and to U.S. investors. Describe any restrictions and
limitations on your ability to
distribute earnings from the company, including your subsidiaries, to
the parent company
and U.S. investors. Please also disclose whether the company has any
cash management
policies.
Prospectus Summary
Overview, page 1
2. We note your response to our prior comment 5 and we reissue the comment.
Please revise
the Overview section of the prospectus summary to provide an equally
prominent
discussion of the challenges faced by the company and the risks and
limitation that could
harm the business or inhibit strategic plans. In this regard, please
note that clinical data
obtained in China may not be accepted by the FDA or other foreign
regulators to support
ongoing or future clinical trials, that the company only has an approved
product in China,
and that the outcome of clinical trials is uncertain.
3. We note your response to our prior comment 6 and resissue the comment.
Please revise
the prospectus to remove all statements concluding or implying safety or
efficacy other
than those relating to olverembatinib as approved in China, as such
determinations are
solely within the authority of the FDA and comparable foreign regulatory
bodies. For
example, but without limitation, we note the following:
Your statement that lisaftoclax, with its short half-life,
patient-friendly ramp-up
schedule, reduced risk of drug-drug interactions, or DDIs, favorable
safety profile and
high response rate, can serve as a backbone molecule for combination
therapies for
many hematological malignancies, including and beyond CLL/SLL.
Your references to positive preliminary results.
Your references to "abundant real-world patient safety and efficacy
data".
Your statements that your pipelines demonstrate a robust efficacy
and safety
profile .
Your statement that you have identified several compounds that
are capable of
rapidly reducing the levels of the Bcl-xL protein in human cancer
cell lines and
thereby inhibiting cancer cell growth in human cancer cell lines
that are dependent on
Bcl-xL.
You may present clinical trial end points and objective data resulting
from trials without
concluding safety and efficacy, and you may state that your product
candidates
are well tolerated, if accurate.
4. We note your response to our prior comment 7 and we resissue the
comment. In all
instances outside of your discussion of strategy, please remove
references to your product
candidates and future pipeline candidates as potentially "best-in-class"
or "first-in-class"
products. Given the current stage of development of the company s
products, such claims
are speculative and premature.
5. We note your response to our prior comment 9. Please revise your
disclosure to either
include a defined term for your use of "global" in the context of
"global registrational"
trials, or to specifically name each country in which regulatory trials
are taking place in
each instance where the term is used. Please also ensure footnote 2 to
the pipeline table is
revised accordingly.
August 15, 2024
Page 3
6. We note your response to our prior comment 11 and reissue the comment.
Please revise
this section to include a discussion of your agreements with
AstraZeneca, Innovent,
Merck, and Pfizer. We note your qualification that these are "clinical
collaboration
agreements" and as such, this discussion should describe the
cost-sharing arrangement,
including each party's rights and obligations, how much of the costs
each party is
obligated to fund and what rights, if any, each party will have to the
data resulting from
the trial. To the extent that these agreements provide any rights to
olverembatinib and
lisaftoclax, please describe such rights. Alternatively, please provide
an analysis
supporting the statement in your response letter that the company is not
substantially
dependent on each agreement. See Item 8 of Part II of Form F-1 and Item
601(b)(10) of
Regulation S-K.
7. We note your statement in this section and elsewhere that the company is
eligible to be
paid "double-digit royalties on net sales" under the Takeda exclusive
option agreement.
Please revise this disclosure in all places in which it appears to
disclose the royalty rate
within a range of ten percentage points. As drafted, "double-digit
royalties" could refer to
a royalty of 10% or 99%.
Risk Factors
Even if this offering is successful, we will need to obtain additional
financing to fund our
operations..., page 24
8. We note your response to our prior comment 17. Please further revise
your disclosure to
identify the local governments that provided subsidies to fund the
company s operations
in the past.
We have entered into collaborations and other relationships with leading
biotechnology
companies and research institutions..., page 78
9. We note the newly added disclosure on pages 79 and 80 that the company
cannot
guarantee that Takeda will not seek to change the terms of the exclusive
option agreement
and that the company cannot guarantee that Takeda will exercise the
option "on terms
acceptable" to the company. Please revise your disclosure to explain
these statements in
light of the executed agreement entered into between the parties.
Capitalization, page 127
10. We note your revised disclosures in response to comment 22. Please
explain to us why
interest-bearing bank and other borrowings that are classified as
current liabilities are not
included in your capitalization.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Research and Development Expenses, page 141
11. We note your response to our prior comment 25. Please clarify if you
track your external
research and development costs and explain the level on which costs are
tracked
(compound, target, indications and treatments, etc.). Given the
significance of your
research and development costs, your current disclosure indicating that
you refocused
your resources on developing key product pipelines does not sufficiently
convey to
investors the matters that materially impacted your research and
development expenses.
August 15, 2024
Page 4
Business
Takeda exclusive option agreement, page 200
12. We note your response to our prior comment 16 and we reissue the comment
in part.
Please revise your disclosure regarding the termination provision of the
Takeda exclusive
option agreement to define Option Initiation Period and Option
Exercise Period in the
prospectus itself rather than referring to the agreement.
Note 17 - Investment in a Joint Venture, page F-40
13. We note your response to our prior comment 32. Please disclose the
significant
judgements and assumptions that you used in determining that you have
significant
influence over Suzhou Ascentage Harvest Venture Capital LLP. Refer to
paragraph 9(e)
of IFRS 12.
Please contact Eric Atallah at 202-551-3663 or Daniel Gordon at
202-551-3486 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Tamika Sheppard at 202-551-8346 or Laura Crotty at 202-551-7614 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: David Sharon